Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03656601 |
| Other study ID # |
66574316.4.0000.5505 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2016 |
| Est. completion date |
March 2020 |
Study information
| Verified date |
September 2023 |
| Source |
Federal University of São Paulo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Evaluation of the impact of the delivery in the system of suspension and sustentation of
pelvic floor, by 3D ultrasound and quality of life questionnaires.nt
Description:
The pelvic floor is a complex group of muscle, fascia and connective tissue that recover the
basis of the pelvic bones, forming the system of suspension and sustentation of the pelvic
organs. Different events that happen during the life of women, like pregnancy, delivery, gain
of weight and hormonal alterations from the menopause, may affects the strength of the
muscles and of other structures that supports pelvic organs. The importance of the balance of
the pelvic organs in maintenance of quality of life have been recognized in literature last
years. Different studies established association between sexual disfunction and emotional
dissatisfaction, as well as reduction of well-being in that women. The urinary incontinence
and anal incontinence are also important factors that compromised quality of life and can
provoke harmful effects over the self-esteem of women and diminish relationship. The 3D
ultrasound (3D UD) is a non-invasive method, reproductible, and technically easy of evaluate
the pelvic floor. Different routes may be used, but the transperineal is the most common. By
this route is possible to evaluate the pelvic floor anatomy, as well as its disfunction into
deep planes, what we can not afford only with the physical exam.
The objective was to evaluate the impact of the delivery on the pelvic floor, by the 3D
ultrasound evaluation and to correlate it with the scores of sexual questionnaire (FSFI),
urinary questionnaire (King´s) and anal incontinence questionnaire ( specific questions about
loss of gases).
This is a transversal study of a cohort of women in reproductive age recruited from May 2016
to June 2018. The clinical and US evaluation were performed at the same medical visit.
Patients signed the consent term and answered the questionnaires (King's health quality of
life questionnaire, FSF-I (Female Sexual Function - Index, and a scale of anal incontinence)
before the ultrasonographic exams. The USG evaluation was performed using GE Voluson 730
expert systems with RAB 8- 4 Mhz volume transducers with an 85-degree acquisition angle. The
exams were performed with patient in supine position with hip flexed and using slightly
abduced, after voiding. The US transducer was placed on the perineum in the midsagittal
position and volumes were obtained at rest, at maximum Valsalva, and perineal contraction.
The volumes datasets were analyzed offline by of the authors. They were blinded and the
average values were considered.
The studied parameters was the hiatal area (HA), the antero-posterior diameter (PA),
transverse diameter (TD) and the muscle thickness (MT). The measures were obtained by the
OmniView VCI mode.
Statistical analysis was performed using student t, ANOVA and Tukey. P value of <0.05 was
considered statistically significant.
